Vaccine Development And Manufacturing

Author: Emily P. Wen
Publisher: John Wiley & Sons
ISBN: 1118870905
Size: 11.79 MB
Format: PDF, Docs
View: 917
Download Read Online
The process stability of a live attenuated bacterial vaccine strain (e.g., Salmonella
typhi Ty21a) depends markedly on the growth parameters used to produce the
vaccine (see Fig. 10.2). The precise mechanism for these differences has not
been described, but it is clear that a prudent stabilization strategy involves the
optimization of the upstream process manufacturing conditions prior to
formulation development. Despite the abundance of biopharmaceutical products
that are ...

Process Validation In Manufacturing Of Biopharmaceuticals

Author: Gail Sofer
Publisher: CRC Press
ISBN: 1420001655
Size: 67.53 MB
Format: PDF, Docs
View: 5367
Download Read Online
ANALYTICAL TESTING AND CONTROL STRATEGIES Analytical testing is one
of the most important programs in the biopharmaceutical industry. It starts with
raw materials and systems testing and continues through production, purification,
formulation, packaging, and storage (1). Analytical testing helps to monitor,
control, maintain, and ensure product quality and batch-to-batch consistency. The
quality and consistency depend not only on efficient process controls but also on
sound ...

Quality By Design For Biopharmaceuticals

Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Size: 63.99 MB
Format: PDF, ePub
View: 3619
Download Read Online
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the ...

Continuous Manufacturing Of Pharmaceuticals

Author: Peter Kleinebudde
Publisher: John Wiley & Sons
ISBN: 1119001323
Size: 23.92 MB
Format: PDF, Docs
View: 259
Download Read Online
"This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment.

Continuous Processing In Pharmaceutical Manufacturing

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527673709
Size: 80.69 MB
Format: PDF, Kindle
View: 4543
Download Read Online
The information and knowledge gained from pharmaceutical development
studies and manufacturing experience provide scientific understanding to
support the establishment of the design space, specifications, and manufacturing
controls. At a minimum, those aspects of drug substances, excipients, container
closure systems, and manufacturing processes that are critical to product quality
should be determined and control strategies justified. Critical formulation
attributes and process ...